Dr. Kalpesh Shah

Executive Leader: Clinical Trials, Bioequivalence and Phase I Studies Clinical Research Operations Management Biosimilar Development PK and BE studies Profile Summary With over two decades of robust experience in leading business change, that delivers sustainable operational outcomes and long-term success in the field of clinical research. Spearheaded the clinical research department for early and late-phase development programs for diverse projects. Demonstrated success in consistently providing leadership, strategic oversight, and guidance on Clinical Operations to ensure quality, timeline, resources, and budget goals are met. Provided input on operational components of legal documentation and statements of work as required for new and returning sponsors, vendors, and suppliers. Comfortable multi-tasking in a fast-paced environment and able to adjust workload based upon changing priorities. Assisted as an advocate for clinical operations needs/resources at a senior management level. Demonstrated ability to drive clinical trial activities: i.e. experience in all aspects of study start-up and conduct, regulatory obligations, adverse event reporting, and budgeting. Accomplished Regulatory submission - FDA, EMA, India, and other Emerging markets, including Clinical development plans and strategy towards study conduct, regulatory submission, and approval for NDDS, Biosimilars, generics, Clinical equivalence studies, PK in patients, etc. Influential people manager, build and nurture high performing teams, represent all aspects of Clinical Operations and facilitate updates as required to the Executive Committee, Project Teams, Board of Directors and other key internal stakeholders. Key Skills: Project Management Clinical Operation Medical Writing Strategy Planning Technical Support Business Development Clinical Plan Development Process Improvement Operational Excellence Training and Mentoring Transformation and Innovation Regulatory Submission Clinical Approvals Compliance Management Personal Traits: Big Picture Perspective ~ Influential Leadership ~ Systematic Planner ~ Good Listener ~ Self-Motivated ~ Recognized People Manager.

• GATE Qualified (91.31%), IIT, Mumbai.

Indoor games i.e. Chess. Bollywood Music, folk music,  etc.